Diabetes is a chronic disease in which the body cannot properly regulate glucose metabolism. An estimated 9% of the U.S. population has been diagnosed with diabetes. Because of complications associated with diabetes, such as neuropathy, a weakened immune system, and narrowed arteries, wounds in diabetic subjects are particularly difficult to heal—they are prone to infection and either do not heal or heal slowly. Thus, there is a need for compositions that are effective in healing wounds such as those from diabetic subjects.
Cell transplantation has been used in regenerative medicine for musculoskeletal disorders as well as degenerative conditions such as diabetes with limited success. Limitations of earlier approaches include loss of cell viability and function following transplantation.
Currently available products for the management of diabetic foot ulceration include the growth factor, becaplermin (REGRANEX™), and bioengineered skins, APLIGRAF™ and DERMAGRAFT™. However, efficiency of these products to heal ulcers has been limited. Thus, there is a need for a more efficient therapy that is also easier and less expensive to produce. This invention addresses these needs.